In December 1997, following a period of public
consultation, the Human Genetics Advisory Commission published
a report entitled `The Implications of Genetic Testing for Insurance'.
This report recommended the establishment of a mechanism to evaluate
the scientific and actuarial evidence presented in support of
the use of specific genetic tests for insurance products.

The Government response to this report was published
on 5 November 1998. Paragraph 16 of the Government response states
that:

"The Government believes that genetic test
results should only be taken into account by insurers in making
underwriting decisions where the relevance of the test results
to the risk assessment relating to particular types of insurance
product has been demonstrated. We welcome the ABI's commitment
to this principle in its Code of Practice. The Government also
agrees with the HGAC that an effective mechanism should be established
to evaluate the reliability and actuarial evidence relating to
the use of specific genetic test results by insurers. Any such
mechanism should involve people with sufficient expertise and
independence to meet concerns about the interpretation of these
test results. The mechanism should be permanent and be used to
evaluate all new genetic tests as they are developed. The Government
intends to consult with the industry, HGAC and ACGT on how this
mechanism can be put in place within a period of three months.
The membership of the mechanism should include members of the
ACGT with the necessary expertise and representatives of the insurance
industry and the actuarial profession."

The establishment of the Genetics and Insurance
Committee (GAIC) in April 1999 fulfilled the Government's commitment
to establish an independent review body.

John Durant, the first Chairman of GAIC, was
appointed from among the members of the Advisory Committee on
Genetic Testing. Other members have been nominated by the Association
of British Insurers, the Chief Medical Officer, the Faculty and
Institute of Actuaries and the Genetic Interest Group.

(i) How the GAIC interprets its role
in the regulatory system. Please could you clarify whether you
consider purely the scientific accuracy of tests or also the wider
implications of testing.

The Genetics and Insurance Committee has a very
specific remit to evaluate the scientific and actuarial relevance
of genetic tests proposed for use by the insurance industry in
setting insurance premiums. The terms of reference of GAIC are:

 to develop and publish criteria for
the evaluation of specific genetic tests, their application to
particular conditions and their reliability and relevance to particular
types of insurance;

 to evaluate particular tests against
those criteria and promulgate is findings; and

 to report to Health, Treasury and
Department of Trade and Industry Ministers, on proposals received
by GAIC from insurance providers and the subsequent level of compliance
by the industry with the recommendations of GAIC.

The Committee's terms of reference do not include
consideration of the wider ethical and social issues around the
principle of the use of genetic test results by insurers. However,
the members of GAIC have been very mindful of the wider context
in which they are working. In assessing tests they have been concerned
to protect the rights of the individual who has disclosed a genetic
test result as well as the rights of insurers.

The Committee is aware of the role of the Human
Genetics Commission in considering the wider picture on genetics
and insurance. As well as being Chairman of GAIC, Professor Durant
was also a member of the Human Genetics Commission and ensured
that the Commission was aware of GAIC's work. He referred to the
Commission the wider issues raised in GAIC's consultation on its
criteria for assessment of tests. GAIC has also been working very
closely with the HGC in its current consideration of genetics
and insurance.

(ii) The work you are currently undertaking,
especially in relation to the verification of genetic tests for
use by insurers.

GAIC's first task was to draw up the procedure
to be followed before deciding whether results of specific genetic
tests can continue to be used for insurance purposes, the criteria
for making such decisions and guidelines for insurance providers
wishing to submit information on genetic tests that were to be
used for insurance purposes.

The Committee spent several meetings in 1999
drafting and refining questions and guidance notes for applicants.
These take the form of an application form of 11 questions covering
the details of the genetic condition being tested for, the accuracy
and reliability of the tests used to detect it and the relevance
of the test results to decisions about insurance underwriting.

The draft application form and accompanying
notes were subject to a wide public consultation in February 2000
and the final version was published in June 2000. A copy of the
GAIC 'Notes to accompany applications to GAIC for approval to
use genetic test results for insurance risk assessment' is enclosed.[5]

Once this week was completed, the Committee
was ready to consider applications for assessment of genetic tests
and, in particular, the ten tests for seven genetic conditions
currently used by the insurance industry and covered by the Association
for British Insurers' Code of Practice on Genetic Testing.

The procedure which is used to review applications
to GAIC by the insurance industry is as follows:

1. The Secretariat will acknowledge all applications
within seven days.

2. They will then be subject to an initial
14 day review by the Committee and Secretariat. If necessary,
the applicant may be asked to submit additional information and
clarification at this stage.

3. The application will then be sent out
to outside reviewers from a panel to be appointed by GAIC. This
will provide an expert review of the genetics (by a clinical geneticist
and/or a population geneticist / epidemiologist) and the actuarial
evidence (by an actuary nominated by the Faculty and Institute
of Actuaries).

4. A copy of the application will also be
sent for comment to the appropriate patient support group(s) for
the condition under discussion.

5. The application and reviewers' comments
will be assessed by the GAIC at a meeting and a decision made.
Interested observers will be permitted to attend the meeting by
arrangement with the Secretariat.

6. GAIC's advice on the use of the genetic
test by insurers will be forwarded to Ministers. The applicant
should be notified of the decision of the Committee within 14
days of the meeting.

All applications are treated in confidence during
the assessment process but, when determined, both the test of
the application and details of the decision and reasons for it
will be published by GAIC on its website.

The ABI has submitted applications for the following
conditions:

 Huntingdon's Disease

 Early onset Alzheimer's Disease (PSI
and APP genes)*

 Hereditary breast/ovarian cancer
(BRCAI and BRCA2 genes)*

 *awaiting initial review

For each condition, separate applications have
been made covering life insurance, critical illness insurance,
income protection insurance and long-term care insurance (not
breast/ovarian cancer).

ABI members had also been using test results
for a further four conditions, for which applications have not
been submitted to GAIC, as follows:

 Myotonic dystrophy

 Familial adenomatous polyposis

 Multiple endocrine neoplasia

 Hereditary motor and sensory neuropathy

In accordance with their agreement with GAIC,
the ABI has indicated its willingness to advise its members to
cease to use results from these tests and to re-underwrite any
individuals who may have been disadvantaged by the disclosure
of a test result for one of these conditions since November 1998,
when the ABI Code of Practice was introduced. A similar undertaking
has been given in respect of any tests in current use for which
GAIC approval is refused.

GAIC has commenced its review of the applications
submitted and announced its first decision in October 2000, namely
that the reliability and relevance of the genetic test for Huntingdon's
Disease is sufficient for insurance companies to use the result
when assessing applications for life insurance. Review of the
remaining applications is ongoing and will be completed in the
next six to nine months.

GAIC will also have a monitoring role in the
future to assess usage of genetic test results by insurers and
compliance with the terms of GAIC's decisions.

(iii) The scientific evidence that GAIC bases
its decision upon

GAIC recognises that there are three conditions
that need to be met before a test can be deemed to be suitable
for use when assessing insurance proposals:

 Is the test technically reliable?
Does it accurately detect the specific changes sought for the
named condition? This is the technical relevance of the test.

 Does a positive result in the test
have any implications for the health of the individual? This is
the clinical relevance of the test.

 Do the health implications make any
difference to the likelihood of a claim under the proposed insurance
product? This is the actuarial relevance of the test.

Only where all three of these conditions are
satisfied can a test be approved by GAIC for consideration by
the insurance industry in setting premiums for insurance.

Full details of the evidence to be submitted
and the review procedure are given in the answer to (ii) above
and in the attached "Notes to accompany applications to GAIC
for approval to use genetic test results for insurance risk assessment".

(iv) What future developments you expect
in the use of genetic tests by the insurance industry and, in
particular, whether the GAIC anticipates companies using tests
for diseases that are not single gene defects, or where there
are non-genetic influences (for example, heart disease).

The tests that have been used by the insurance
industry and have been the subject of the initial applications
to GAIC have all been for genetic conditions caused by changes
in a single gene that are very likely to lead to serious ill health
or disability and that are therefore most relevant to the setting
of premiums for life and health insurance.

GAIC has stated that, at this stage, genetic
tests that do not accurately predict ill health (including tests
that are low penetrance or multi-factorial) and those that are
predictive of less serious conditions will not be candidates for
GAIC consideration. For most genetic polymorphisms and multi-factorial
conditions, the current level of understanding of the relative
importance of genetic and other factors for predisposition to
disease and excess insurance risk is likely to be sufficient to
make a case for use of the genetic tests by insurers. It is possible
that in the future there will be applications for multi-gene defects
and defects where there are significant environmental influences.
GAIC's assessment criteria should ensure that approval to use
the results of such tests is only given in circumstances where
a test result does have implications for the health of the individual
and these health implications do make a difference to the likelihood
of claim under the insurance product.